FDA Introduces Pilot Programs For EtO Sterilization Initiatives

The United States Food and Drug Administration (FDA) announced new initiatives to spur innovation in Ethylene Oxide (EtO) sterilization for medical devices. EtO has recently come under pressure as a practice due to the hazardous release of ethylene oxide into the environment from facilities performing the sterilization process. This year, the United States Environmental Protection Agency (EPA) has issued warnings to 2 EtO sterilization facilities run by Sterigenics that have resulted in work stoppages and shortages of some important medical devices.

In response to the recent EtO issues, the FDA issued 2 innovation challenges to encourage new ideas. The first challenge revolved around identifying new sterilization methods and technologies, with the hope of developing new procedures that don’t rely on ethylene oxide. The second challenges was to come up with revisions to the EtO process that reduce ethylene oxide emissions to as close to zero as possible. The FDA recently chose 12 participants to work on addressing the challenges. In the same announcement, the FDA also announced the EtO Sterilization Master File Pilot Program:

“This voluntary program is intended to allow companies (sterilization providers) that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations.

Under this voluntary program, manufacturers (PMA holders) of Class III devices subject to premarket approval that are affected by such changes may reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a PMA supplement.

This pilot program seeks to ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health.”

Read the entire announcement here: Ethylene Oxide Sterilization for Medical Devices

Hospitals need to continue to monitor the developments in EtO sterilization and other techniques to ensure the safest instruments and devices for their patients. When it comes to flexible endoscopes, hospitals need to determine which infection control procedure is best for them. Whether using sterilization or double washing to reduce the risk for particularly hard to clean scopes such as duodenoscopes, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. Whether reprocessing using HLD or sterilization, make sure that your staff is following the proper processes and protocols each and every time an endoscope is reprocessed. Systems such as iRIScope can display the proper workflow for reprocessing scopes such as duodenoscopes and document the process automatically. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer everyone the peace of mind that your flexible endoscopes are being properly reprocessed every single time.